Device for Alleviating Temporomandibular Joint (TMJ) Pain
United States31 participantsStarted 2024-08-21
Plain-language summary
The goal of this clinical trial is to evaluate the safety and effectiveness of the investigational BTL-043 device in alleviating Temporomandibular Joint (TMJ) pain in adults aged 22 years and older. The main questions it aims to answer are:
Does the BTL-043 device effectively reduce TMJ pain? Does the treatment improve jaw mobility (mandibular range of motion) and reduce the impact of TMJ disorders on daily activities? Is the treatment comfortable and safe for participants?
Participants will:
Receive four 20-minute treatments with the BTL-043 laser, spaced 2 to 10 days apart.
Attend follow-up clinic visits 1 month and 3 months after their final treatment.
Complete questionnaires about their pain levels (Visual Analogue Scale), daily activities (TMD Disability Index), and treatment comfort and satisfaction.
Have their jaw mobility (mandibular range of motion) measured
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults seeking alleviation of pain in the treatment area
* Age 22 years and older
* Voluntarily signed an informed consent form
* Subject is willing to comply with study instructions, to return to the clinic for the required visits
* Willingness to adhere to and continue current pain management plan
* Subjects willing and able to maintain their regular (pre-procedure) diet, exercise and therapy regimen without affecting significant change during study participation
* Subject willing and able to abstain from partaking in any new treatments other than this study procedure to treat TMJ pain
* Women of child-bearing potential\* are required to use birth control measures during the whole duration of the study \*Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
Exclusion Criteria:
* Major systemic diseases - e.g. uncontrolled Diabetes mellitus, systemic lupus erythematosus
* Current pregnancy
* Photosensitivity, medications affecting sensitivity to light
* Tattoos or other higher pigmented regions in the treated area
* Corticosteroids or injections of the treated area within the last 3 months, long-term corticosteroids use
* Anticoagulant therapy, bleeding disorders
* Hemorrhage in the treated area
* Application over the thyroid or other endocrine glands
* Applicati…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in the Visual Analogue Scale (VAS) Pain Score at 3 Months
Timeframe: Baseline and 3 months
2
Change from Baseline in the Temporomandibular Dysfunction (TMD) Disability Index Score at 3 Months